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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients with HIV and Cryptococcal Meningitis  The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients with HIV and Cryptococcal Meningitis
The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients with HIV and Cryptococcal Meningitis
For Condition: Meningitis, Cryptococcal,HIV Infections
Status: Completed
Sponsor(s): Alkermes ,
Synopsis: To evaluate the safety of escalating doses of RMP-7 administered in persons with HIV infection and cryptococcal meningitis and to determine the MTD of the drug. To evaluate the pharmacokinetics, including cerebrospinal fluid (CSF) penetration, of amphotericin B when administered with RMP-7.
Details: Patients receive intravenous RMP-7 added to conventional therapy with intravenous amphotericin B (with or without flucytosine). Treatment continues for 14 days, with follow-up visits 4 and 12 weeks later.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Up to 1 mg/kg amphotericin B for the current episode of cryptococcal meningitis. Patients must have: - HIV infection. - Acute cryptococcal meningitis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Cardiovascular disorders including congestive heart failure, uncontrolled hypertension (seated diastolic blood pressure > 95 mm Hg), or symptomatic ischemic heart disease (angina). - Orthostatic hypotension, defined as a decrease in systolic blood pressure of >= 20 mm Hg upon standing. - Coma. - Other CNS disease (e.g., other intracranial infections) that may interfere with assessment of response. - Opening CSF pressure >= 350 mm or papilledema. (For patients with recurrent disease, evidence of mass effect on either MRI or CT excludes.) - Any concurrent disease that would preclude participation in the study. Patients with the following prior conditions are excluded: - History of any bleeding disorder. - History of active renal or hepatic disease. - Myocardial infarction within the previous 3 months. - Stroke within the previous 3 months.
Total Enrollment:
Location and Contact Information:
UCI Med Ctr
Orange, California, 92668
United States
East Carolina Univ School of Medicine
Greenville, North Carolina, 278584354
United States
UCSD Treatment Ctr
San Diego, California, 92103
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550882
United States
Bowman Gray School of Medicine
Winston Salem, North Carolina, 271571042
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Pennsylvania State Univ / Hershey Med Ctr
Hershey, Pennsylvania, 17033
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Additional Information:
Study ID Numbers: 131A; ALK01-006
Study Start Date:
Record last reviewed: December 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002316
Other Hiv Infections Studies:
1. Treating Genital Herpes to Decrease Risk of HIV Acquisition
2. Phase I/II Study of Curdlan Sulfate
3. A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs
4. Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women
5. A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion Vaccine
Related Studies:
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The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients with HIV and Cryptococcal Meningitis
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